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Home›Malaysia›Comfort Rubber Gloves Industries Sdn. Bhd.

Comfort Rubber Gloves Industries Sdn. Bhd.

Malaysia · Perak
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 12 registration records and 17 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 17 510(k), 0 PMA, 29 excluded
Brazil2 confirmed, 10 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
Same-named companies — This database also contains companies with near-identical names: Comfort Rubber Gloves Ind. Sdn. Bhd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Perak

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11994
11998
22000
22009
12010
12011
22017
12018
12019
22020
22024
12025

FDA listed device types

Latex Patient Examination Glove 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein2025-04-29
USK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)2024-10-25
USK241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential2024-08-06
BR80306640013LUVA PARA PROCEDIMENTO GRANDESCClass I
BR10201230124LUVA DE LÁTEX PARA PROCEDIMENTO NÃO ESTÉRIL (COM PÓ)Class I

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